• 06 Jul 2020
  • 12 min 55
  • 06 Jul 2020
  • 12 min 55

In this episode, NPS MedicineWise CEO Steve Morris speaks with the head of the Therapeutic Goods Administration (TGA) John Skerritt about how the TGA is supporting clinicians and consumers during the COVID-19 pandemic.

They discuss some of the unique challenges the TGA has faced and the way it has adapted to these, along with innovations that should be continued beyond the pandemic period.

Further reading:


The Therapeutic Goods Administration: www.TGA.gov.au

The refreshed NPS MedicineWise COVID-19 information hub: www.nps.org.au/coronavirus

Transcript

Voiceover:

Welcome to the NPS MedicineWise podcast, helping health professionals stay up to date with the latest news and evidence about medicine and medical tests.

Steve Morris:

Hi, I'm Steve Morris, CEO of NPS MedicineWise, and welcome to another podcast in our series related to COVID-19 issues. Today I'm really pleased to say I'm joined by Adjunct Professor John Skerritt, the Deputy Secretary of the Health Products Regulation group, which includes the TGA [Therapeutic Goods Administration]. Welcome John.

John Skerritt:

Hi, g’day, Steve.

Steve Morris:

I'm glad you could make this podcast, John. So look, most of our listeners will know that the TGA is responsible for regulating therapeutic goods, including medicines, medical devices, living blood products, ultimately just for better health and wellbeing of Australians. And look, the pandemic has had significant impacts across the health environment over the last three or four months. So I'm really interested to know from you, John, what the TGA has done to support both clinicians and consumers in terms of medicines management?

John Skerritt:

Well, quite a number of things over the period of the pandemic. So I guess starting at the beginning with clinical trials. While it's largely a notification scheme in Australia, there's been two fundamental shifts. We've had a lot of much earlier engagement with industry and researchers on trial design and manufacturing requirements for clinical trials, and that's quite interesting because generally as only 2% of the world market, we tend to have left it mainly to our American and European cousins to work with companies say on powering of trial designs for vaccines and trial designs for therapeutics. But with a number of local companies and researchers interested in this area, including some quite big partners, of course, we've been engaged at a much earlier stage on those things.

The other thing that we've done with clinical trials is realising that there'll be variations due to COVID-19. In particular relating to the supply of a so-called investigational medicinal product, the medicine used for the trial, and also the need to manage patients remotely rather than, in literally as hands on a way as you traditionally did in clinical trials. These deviations to the original protocol can just be notified to us at the moment. And similarly, we realise the trial start and finish dates will change and participants and so forth. So we've actually been very flexible because of course, especially for COVID, but also to keep the momentum of clinical trials going in Australia, especially if we are coming out of this pandemic earlier than other countries, it was important to have the utmost flexibility.

The other thing that we've done is a range of emergency exemptions that have facilitated access to repurpose therapies, and that's everything from remdesivir through to HIV drugs, through to hydroxychloroquine, which is still undergoing trials, notwithstanding a range of views about its efficacy. One of the biggest things that we've also done to support consumers, in particular, has very close management of medicine shortages. So there's been one to two to three meetings a week at various times of different working parties. I chair a national working party, but there's everyone from healthcare professionals to the supply chain, to industry and procurement people, states and territories involved. And we've done everything from modelling demand of critical medicines to facilitating sourcing and shipping, identifying local supply, looking at dispensing and pricing controls where we've been - not pricing, I should say prescribing controls - where we've been worried about, especially early in the pandemic, panic buying and stockpiling of certain things like Ventolin puffers.

Steve Morris:

Okay. Thank you, John. So that's a lot of areas that you've just provided an overview on, John. Of all those things. What's been the most difficult challenge that the TGA's faced?

John Skerritt:

Well, it was three or four most difficult challenges, rather than choosing any particular one. The obvious one was juggling the additional work. So especially during March into April, we had lots of teams of people working seven days a week, and burnout was a real challenge there. When someone will phone you at ten o'clock on a Sunday night without even apologising for the day or the time to discuss something urgently, you know that you're really starting to run a round the clock business. But that was important to get all sorts of things on the market, not just medicines, but PPE, diagnostic tests, and so forth. And we were juggling that with business as usual.

We've also been working with a large number of new players who either didn't understand or value regulation, again, not so much in the prescription medicines area, but in areas such as personal protective equipment, hand sanitisers, disinfectants, over counter therapies and so forth. These were often companies who had never had any involvement even in medicines before or in devices. And so we spent a lot of time handholding them and advising them on what they could and couldn't do.

That was also a challenge to our funding model, because we're funded on a full fee and charges basis from a regulated industry. And so I had staff, in fact, at one stage I had up to 200 staff, and I would have said that much of their work was, the 200 staff working on COVID. And much of their work I doubt is adequately or appropriately cost recovered. So I think there will be a concern to impacts on our budget.

And the final area that still is a major problem is compliance, both in terms of advertising products inappropriately or just straight out deceptively, and also compliance with people importing products, not putting them on the register, using products for unapproved uses and so forth. So we have almost a thousand compliance cases all up between advertising and other forms of compliance.

Steve Morris:

Thank you, John, in terms of obviously conveying really important messages to consumers, what's been the hardest part of that in terms of getting messages out to consumers in Australia?

John Skerritt:

Well, again, those messages I think have had to evolve as the pandemic has evolved. So early on in March into April, it was what I call the toilet paper thing. Don't go and panic buy pharmaceuticals and stockpile. If you fill multiple repeats for prescription at once, you may make it harder for someone else in the same area to be able to access that medicine. There were local stock outs. So you might have a Northern coast of New South Wales where there were shortages of particular medicine or what was available nationally, but with local flights and other transport affected, that did make it hard. But ‘don't panic buy’ and ‘don't stockpile’ messages were really important to convey to consumers early on.

The other message related to that is that we did struggle also with communication between pharmacists and consumers. And again, it could be said, who got the message, but the medicine might be out of stock at your local pharmacy, but they are available, and they have been available all along if a pharmacist phones a sponsor or a wholesaler. But those messages have evolved because the actual local stock out situation, not withstanding there's still a limited number of domestic and international flights, has calmed down and demand has gone back to normal levels.

Now it's a broader message because people looking at the news, there's always a spirit that, ‘oh, well, the research is done today and the product will be available tomorrow’. And so there's a real need to communicate to consumers, to be realistic about the timeframes for developing vaccines and even therapies. That one small observational study on a particular therapy doesn't equal the fact that it will be of definite clinical value. And even rapidly recruited clinical trials take several months and even longer to report out for a medicine, and that we shouldn't be expecting vaccines this side of Christmas [2020]. So they need to be realistic.

And finally, the other message for consumers is regulatory oversight can be blamed for delaying things. In a way it's a false blame. We've had teams approving products in two or three days, but normally they would have taken two or three months, but with a big team working around the clock, that's what we've been able to do.

And the final message is don't believe everything you see or hear. As I've said, there's been almost a thousand compliance cases so far, we've issued 80 fines, and we'll be in court several times with major court action against certain companies. And people like to hang on to hope, but if you go onto the internet, there's a lot of supposedly cures for coronavirus that frankly are not cures.

Steve Morris:

Yeah, there's certainly a significant problem that's emerged from the lay media I think, John, and everything we can do to try and address that, and create some expectations with consumers is what we should be doing. Obviously you've talked about a number of challenges, John, that's been faced, but also there's obviously been some change in processes and some innovation in this current period. Is there anything from your perspective which you think should be continued beyond the pandemic period?

John Skerritt:

Well, I think the message of never wasting a crisis or a good crisis is an important one. Firstly, on medicine shortages, we brought many more players together and we did things and are doing things such as modelling and predicting supply and demand in a more structured sense. And given that medicine shortages post-COVID are here to stay, they're a challenge in every economy globally and for a range of reasons that challenge is increasing. Some of the ways that we've been managing medicine shortages during COVID I think could and should be continued. I've mentioned also that we haven't traditionally engaged early with the developers of therapies and vaccines in the process, but it's been valuable, in terms of understanding where the technology is up to. It's been hopefully valuable to the researchers and companies developing those medicines and vaccines. And so I think that the greater engagement with developers of therapies and vaccines, which industry and healthcare professionals and researchers wanted all along, it's something we'll have to continue to do, and we should continue to do.

With our business processes have become faster, more nimble and pragmatic, clearly we have to look at safety and adequate consideration all along, but that strengthened internal collaboration. It's broken down a number of silos that can form in any organisation of 700 people.

And finally, the thing that I'm hoping will continue, and this is through the International Coalition of Medicines Regulatory Authorities, Australia is a vice chair at the moment, is stronger international collaboration, and we're getting regular updates on clinical trials and observational studies of products. We're working together on aligned vast to clinical trial protocols. We're sharing information on vaccine pipelines as well, regulatory guidelines, and also information on regulatory flexibilities that each other has implemented. And so that stronger international collaboration I'm hoping should also continue post-COVID.

Steve Morris:

Yeah, sounds good, John. Just finally, John, just if you want to provide information to the list as where they'd find further information around what the TGA's been doing in the COVID-19 period, where would they go?

John Skerritt:

There are COVID web pages on the TGA website. So if you go to www.TGA.gov.au, you can find our COVID hub, which has information on medicines. It's got information on hand sanitisers, it's got information, and the information, for example, on hand sanitisers has been useful for small businesses that have wanted to develop hand sanitisers during this phase. And it has got information on disinfectants and all of the sorts of products that are seen as therapeutic goods in Australia. So you'll see it if you go to the TGA website. So www.TGA.gov.au.

Steve Morris:

Thanks John. Thanks for taking part in the podcast today.

John Skerritt:

Thanks Steve.

Steve Morris:

And as our listeners know, if you want further information about NPS MedicineWise and what we're doing COVID-19, then go to our website, nps.org.au. And any suggestions or questions, please submit them via Twitter or LinkedIn. Okay, thank you very much. Bye.

Voiceover:

For more information about the safe and wise use of medicines visit the NPS MedicineWise website at nps.org.au.